Final manufacture of sipuleucel-T Sipuleucel-TAn investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs).Closefor our clinical trials is currently conducted at a pilot manufacturing facility we operate in Seattle, Washington, and at our manufacturing facility in Morris Plains, New Jersey.
We manufacture the Antigen AntigenA substance that causes the body's immune system to react. This reaction often involves production of antibodies. For example, the immune system's response to antigens that are part of bacteria and viruses helps people resist infections. Cancer cells have certain antigens that can be found by laboratory tests. They are important in cancer diagnosis and in watching response to treatment. Other cancer cell antigens play a role in immune reactions that may help the body's resistance against cancer. CloseDelivery Cassettes for our preclinical studies and clinical trials as recombinant proteins using production methods in compliance with current Good Manufacturing Practices (“cGMP”). The initial build-out of our 158,242 square foot commercial manufacturing facility in Morris Plains, New Jersey was completed in July 2006.
The manufacture of our ACI candidates, such as a dose of sipuleucel-T, begins with a standard cell collection process called leukapheresis. LeukapheresisA blood collection process that isolates a patient's white blood cells.Close The resulting cells are then transported to a manufacturing facility, processed and returned to a health care provider for infusion into the patient. We rely upon blood banks, hospitals and other health care providers to perform leukapheresis for our clinical trials.
The patient cells derived from the leukapheresis process are transported to a manufacturing facility where final manufacturing of sipuleucel-T occurs before it is then transported to a health care provider for infusion into the patient.
To learn more about our manufacturing process, visit our new site, ACTIVATION.
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